CN110597950B - Batch record auditing process control method and device based on deviation management - Google Patents
Batch record auditing process control method and device based on deviation management Download PDFInfo
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Abstract
The invention discloses a batch record auditing process control method based on deviation management, which is used for acquiring test data in an electronic batch record; analyzing deviation information of each test data, and recording the deviation information and the test data in the electronic batch record; displaying the time content and the deviation data of the test data in a page form according to the analyzed content of the electronic batch record to form an audit page; and according to the displayed content, carrying out information tracing and checking on the displayed items in the audit page, and inputting opinions in the audit page. In the embodiment of the invention, the basic data for auditing is directly obtained from the electronic batch records, so that the data risk brought by interface calling is reduced, and the consistency of the data is ensured; the production execution system is oriented, an interface form is adopted, a deviation management system of quality modules is integrated, decoupling requirements among the modules are met, rule risks in the implementation process are reduced, implementation difficulty of users is lowered, and compliance of the system is guaranteed.
Description
Technical Field
The invention relates to the technical field of experiment auditing processing, in particular to a batch record auditing flow control method and device based on deviation management.
Background
The method is suitable for an experiment execution system (LES) or an electronic experiment recording system (ELN) used by inspection and analysis institutions such as a scientific research laboratory, a pharmaceutical enterprise quality control laboratory, a third-party detection laboratory and the like, when recording and auditing of an experiment process are executed, the state and retrospective information of each datum need to be recorded and checked, usually, the experimental data are given in the form of a table or a report and the like, but in the auditing process, the source tracing management of wrong data is needed, and an auditing page needs to have a faster checking mode.
Disclosure of Invention
The embodiment of the invention provides a batch record auditing process control method and device based on deviation management, which are used together with an electronic batch record module, and provide a quick review list of auditing opinions and an opinion input function below an auditing page; in the batch recording page, functions of page navigation, deviation marking, deviation quick positioning and the like are provided.
The first aspect of the embodiments of the present invention provides a batch record auditing process control method based on deviation management, which may include:
acquiring test data in the electronic batch records; analyzing deviation information of each test data, and recording the deviation information and the test data in the electronic batch record;
displaying the time content and the deviation data of the test data in a page form according to the analyzed content of the electronic batch record to form an audit page;
and according to the displayed content, carrying out information tracing and checking on the displayed items in the audit page, and inputting opinions in the audit page.
Further, the forming of the electronic batch record includes:
acquiring experimental process data of each experiment and forming a record containing time, experimental parameters and experimental contents; each record corresponds to a unique tag code.
Further, analyzing deviation information of each test data and recording the deviation information in the electronic batch record together with the test data comprises:
comparing each record with standard data under the same experiment, and marking the data exceeding the error threshold range as deviation information;
forming a new electronic batch record by all deviation information of the same record and the record for updating;
the deviation information is embodied in the form of numbers in the audit page.
Furthermore, a skip channel is formed between each deviation information and the data in the electronic batch records, and the deviation information is checked to realize the search in the electronic batch records.
Furthermore, the display items in the audit page comprise experiment names, experiment codes, experiment time and deviation information data;
the experimental code is a unique code.
A second aspect of the embodiments of the present invention provides a batch record auditing process control apparatus based on deviation management, including:
the experimental data recording module is used for recording experimental data and forming an electronic record;
the deviation information module is used for comparing the experimental data in the experimental data recording module with the standard experimental data and recording the data exceeding the error threshold value to form deviation information;
the auditing module reads the data in the experimental data recording module and the deviation information module to form the display content of the experimental data;
and the entry module and the auditing module are positioned under the same page and are used for entering the auditing opinions.
Further, the experimental data recording module comprises:
acquiring experimental process data of each experiment and forming a record containing time, experimental parameters and experimental contents; each record corresponds to a unique tag code.
Further, the deviation information in the deviation information module is embodied in the form of numbers in the auditing module.
Furthermore, the display item of the auditing module comprises an experiment name, a unique experiment code, experiment time and deviation information data.
Furthermore, the deviation information data in the auditing module and the corresponding data in the deviation information module are correspondingly provided with a skip channel in a one-to-one manner;
and the data in the deviation information module and the corresponding position in the experimental data recording module are correspondingly provided with a jump channel in a one-to-one manner.
In the embodiment of the invention, the basic data for auditing is directly obtained from the electronic batch records, so that the data risk brought by interface calling is reduced, and the consistency of the data is ensured; the production execution system is oriented, an interface form is adopted, a deviation management system of quality modules is integrated, and decoupling requirements among the modules are met; the auditing process designed according to the requirements of GMP regulations reduces the risks of the regulations in the implementation process, reduces the implementation difficulty of users and ensures the compliance of the system.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
Fig. 1 is a schematic flowchart of a batch record auditing process control method based on deviation management according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of a list page of batch record reviews for a control method;
FIG. 3 is a schematic view of a batch record review main page of the control method;
FIG. 4 is a schematic diagram of the deviation indication in the batch record page of the control method;
FIG. 5 is an audit flow diagram of the control method;
fig. 6 is a structural diagram of a batch record auditing process control device based on deviation management according to an embodiment of the present invention.
Detailed Description
In order to make the objects, features and advantages of the present invention more obvious and understandable, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the embodiments described below are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The technical scheme of the invention is further explained by the specific implementation mode in combination with the attached drawings.
In the description of the present invention, it is to be understood that the terms "upper", "lower", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, are merely for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed in a particular orientation, and be operated, and thus, are not to be construed as limiting the present invention.
As shown in fig. 1, the batch record auditing process control method based on deviation management may include the following steps:
s101, acquiring test data in the electronic batch records; the deviation information for each test data was analyzed and recorded in the electronic batch record along with the test data. The forming of the electronic batch record includes: acquiring experimental process data of each experiment and forming a record containing time, experimental parameters and experimental contents; each record corresponds to a unique tag code to enable differentiation.
It can be understood that after the experiment production is completed, the receiving end of the system is used as a front-end acquiring end, the generated information of the electronic batch records is automatically loaded, and the standardized experiment data of the same type in the database is called according to the current experiment type for comparison to form corresponding deviation information. Of course, the determination of the deviation information needs to be determined by setting an error threshold of the experimental data, and a smaller threshold means a higher probability of occurrence of the deviation information and a higher required experimental accuracy.
And forming a new electronic batch record with all deviation information of the same record and the record for updating.
Meanwhile, in the step, the deviation information can be stored in a link channel mode, namely, the deviation information can be directly moved to the corresponding position of the electronic batch record by clicking the related link of the deviation information.
The deviation information is embodied in the form of numbers in the audit page.
S102, displaying time content and deviation data of the test data in a page form according to the analyzed content of the electronic batch record to form an audit page;
it can be understood that, in the previous step, the deviation information is matched with the data of the electronic batch records one by one, the information forms a visual display, the display content is as shown in fig. 2-3, accurate experiment content is not needed, and only some visual data including the name, the unique code, the number of the deviation information and the like of the experiment are needed, so that the trial and error of the completely qualified experiment data on the auditing page is not needed, and the problematic data, namely the part with the deviation data, can be directly retrieved.
And S103, according to the displayed content, performing information tracing and checking on the displayed items in the audit page, and inputting opinions in the audit page.
It can be understood that the details, the weighing records and the feeding records of the current batch records can be quickly selected through the functional buttons on the batch record auditing page, and the product can be quickly traced and checked in a deviation manner. And a quick viewing list of the audited opinions and an opinion entry function are provided below the audit page.
And finishing the treatment on the approved experimental data. And generally, auditing and non-passing processing is performed on the data which are not approved.
According to the method, WebService provides background service, basic data for auditing are directly obtained from the electronic batch records, data risks brought by interface calling are reduced, and data consistency is guaranteed. The production execution system is oriented, an interface form is adopted, a deviation management system of quality modules is integrated, and decoupling requirements among the modules are met; the auditing process designed according to the requirements of GMP regulations reduces the risks of the regulations in the implementation process, reduces the implementation difficulty of users and ensures the compliance of the system.
Referring to fig. 6, a batch record auditing process control device based on deviation management according to an embodiment of the present invention is described below, and as shown in fig. 6, the batch record auditing process control device based on deviation management may include an experimental data recording module 101, a deviation information module 102, an auditing module 103, and an entry module 104.
The experimental data recording module 101 is used for recording experimental data and forming an electronic record;
the deviation information module 102 is used for comparing the experimental data in the experimental data recording module with the standard experimental data, and recording the data exceeding the error threshold value to form deviation information;
the auditing module 103 is used for reading the data in the experimental data recording module and the deviation information module to form the display content of the experimental data;
and the entry module 104 is positioned under the same page as the auditing module and is used for entering the auditing opinions.
It should be noted that, the device makes the batch record auditing process control process consistent with the description in the method embodiment, and for detailed description, reference may be made to the method embodiment, which is not described herein again.
The experimental data recording module 101 includes:
acquiring experimental process data of each experiment and forming a record containing time, experimental parameters and experimental contents; each record corresponds to a unique tag code.
It is understood that the experimental data recording module 101 is used for recording each experimental data, and the recorded action is actually recorded by the operator in the experimental process. The experimental data recording module 101 can only correspond to one experimental data, and the record of each experimental data recording module 101 corresponds to a unique label.
The deviation information in the deviation information module 102 is embodied in the form of numbers in the audit module. Further, in the audit module, the number of offset information is provided with a link to each offset information link in the offset information module 102. Each deviation information link can link to a specific location of each deviation information.
The display items of the auditing module 103 include experiment names, unique experiment codes, experiment time and deviation information data (embodied in number form), and in the page of the auditing module, the user has no modification authority but can only review relevant experiment information. In all data, only the deviation information data can further check the information, so that the display action of quickly positioning the deviation can be realized.
As a specific embodiment, the offset information data in the auditing module and the corresponding data in the offset information module are correspondingly provided with a skip channel in a one-to-one manner; and the data in the deviation information module and the corresponding position in the experimental data recording module are correspondingly provided with a jump channel in a one-to-one manner, and the jump channel can appear in a link form.
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and variations can be made without departing from the technical principle of the present invention, and these modifications and variations should also be regarded as the protection scope of the present invention.
Claims (2)
1. A batch record auditing process control method based on deviation management is characterized in that,
acquiring test data in the electronic batch records; analyzing deviation information of each test data, and recording the deviation information and the test data in the electronic batch record;
the forming of the electronic batch record includes:
acquiring experimental process data of each experiment and forming a record containing time, experimental parameters and experimental contents; each record corresponds to a unique tag code;
the analyzing deviation information of each test data and recording the deviation information and the test data in the electronic batch record comprises the following steps:
comparing each record with standard data under the same experiment, and marking the data exceeding the error threshold range as deviation information;
forming a new electronic batch record by all deviation information of the same record and the record for updating;
the deviation information is embodied in the form of number in the audit page;
displaying the time content and the deviation data of the test data in a page form according to the analyzed content of the electronic batch record to form an audit page; forming a skip channel between each deviation information and the data in the electronic batch records, and searching in the electronic batch records by checking the deviation information; the display items in the audit page comprise experiment names, experiment codes, experiment time and deviation information data; the experiment code is a unique code;
and according to the displayed content, carrying out information tracing and checking on the displayed items in the audit page, and inputting opinions in the audit page.
2. A batch record auditing process control device based on deviation management is characterized in that,
the batch record auditing process control device based on deviation management comprises:
the experimental data recording module is used for recording experimental data and forming an electronic record;
the deviation information module is used for comparing the experimental data in the experimental data recording module with the standard experimental data and recording the data exceeding the error threshold value to form deviation information;
the auditing module reads the data in the experimental data recording module and the deviation information module to form the display content of the experimental data;
the input module and the auditing module are positioned under the same page and are used for inputting auditing opinions;
the experimental data recording module comprises:
acquiring experimental process data of each experiment and forming a record containing time, experimental parameters and experimental contents; each record corresponds to a unique tag code;
the deviation information in the deviation information module is embodied in the auditing module in a number mode;
the display items of the auditing module comprise experiment names, unique experiment codes, experiment time and deviation information data;
the deviation information data in the auditing module and the corresponding data in the deviation information module are correspondingly provided with a jump channel in a one-to-one manner;
and jump channels are correspondingly arranged at the corresponding positions of the data in the deviation information module and the experimental data recording module in a one-to-one manner.
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